Efficacy and safety of lurasidone in acutely psychotic patients with schizophrenia: A 6-week, randomized, double-blind, placebo-controlled study.

AIM To evaluate the efficacy of lurasidone in acute schizophrenia in Japan and other countries. METHODS Subjects, ages 18-74, diagnosed with schizophrenia were to be randomized to lurasidone 40 mg/day or placebo. The primary efficacy endpoint was change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score at Week 6. Secondary efficacy assessments included the Clinical Global Impression-Severity Scale (CGI-S). Safety endpoints. included adverse events, laboratory, and electrocardiogram parameters. RESULTS 483 subjects were randomized to lurasidone or placebo; 107 subjects were from Japan. Mean changes from baseline scores at week 6 endpoint in PANSS total scores were - 19.3 in the lurasidone group and - 12.7 in the placebo group (treatment difference: P < 0.001, effect size = 0.41). Change from baseline for week 6 CGI-S scores were - 1.0 for lurasidone and - 0.7 for placebo (treatment difference: P < 0.001, effect size = 0.41). All-cause discontinuation during the 6-week, double-blind period was 19.4% for lurasidone and 25.4% for placebo, and discontinuation due to adverse event were 5.7% for lurasidone and 6.4% for placebo. The common treatment-emergent adverse events occurred in more than 2% on lurasidone and at a rate at least twice that of the placebo group were akathisia (4.0%), dizziness (2.8%), somnolence (2.8%), abdominal discomfort (2.0%) and asthenia (2.0%). No significant changes in body weight and metabolic parameters were observed. CONCLUSION Lurasidone 40 mg once daily dosing demonstrated efficacy in a patient population with acute schizophrenia including subjects from Japan and it was generally safe and well-tolerated. This trial was registered with EudraCT(no:2016-000060-42). This article is protected by copyright. All rights reserved.